The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.
This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
947
Real-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital.
7-day mortality rate
Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
Time frame: 7 days
Early neonatal morbidity within the first 7 days
Percentage of neonates classified as having early neonatal morbidity, defined as diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging (grade 3 or 4 intraventricular hemorrhage per Papile classification or cerebellar hemorrhage), or seizures on electroencephalogram in the first seven days of life
Time frame: 7 days
Composite outcome of early mortality and morbidity
Percentage of neonates classified as having early neonatal mortality or morbidity, defined as dying or diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life.
Time frame: 7 days
Highest level of resuscitation received in the delivery room
The highest level of delivery room resuscitation during the first hour of life, on a scale of 1-6, corresponding to routine care; oxygen and/or continuous positive airway pressure (CPAP); positive pressure ventilation (PPV); advanced airway placement (endotracheal tube or laryngeal mask); chest compressions; or epinephrine administration, respectively.
Time frame: First hour of life
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